Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Argon Medical Devices, Vesseloops, Blue Maxi, Two Latex free silicone vessel ties. Quantity: 1 box of 10 each (2 per pouch), sterilized by ETO, Federal law restricts this device to sale by or on the order of a physician. Manufactured by Sterion Incorporated, Ham Lake, MN for Argon Medical Devices, Athens, Texas.

FDA Recall Z-1044-04 · Posted 2004-07-20

Recall StatusTerminated
Product CodeKDC
Date Initiated2004-06-22
Date Terminated2005-11-03
Product Quantity5604 units

Reason for Recall

Inadequate closure compromising sterility.

Firm Action

The recall was initiated by certified letter on 06/22/2004.

Root Cause

Other

Distribution Pattern

Distribution ocurred in the following states PA, MO, NJ, OH, CA, VA, NM, TX, NE, and to Tokyo, Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑